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9/20/20254 min read
Flow Cytometer
XF-1600
Instructions for Use
for upgraded XF-1600 to
14 fluorescence detection channels
Code No. CF819831 en-eu
PRINTED IN JAPAN
Date of Issue or Revision: 04/2025
Document Version: 1.0
Software Version: 0 onwards
© SYSMEX CORPORATION
Revision history
XF-1600 Instructions for Use
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Revision history
04/2025
Initial issue
Document version: 1.0
Software version: 0
Revision history
XF-1600 Instructions for Use
4/14
Table of contents
XF-1600 Instructions for Use
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6
Table of contents
Revision history 3
Chapter 1 Introduction 7
1.1 Points to note about this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.2 Symbols used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Chapter 2 Instrument specifications 9
2.1 Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Chapter 3 Cytometer QC and setup 11
3.1 Registering lot information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Chapter 4 Registering panel/subset panel and
workitems 13
4.1 Reviewing subset panels and QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.2 Workitems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Table of contents
XF-1600 Instructions for Use
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Chapter 1 Introduction
XF-1600 Instructions for Use
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Chapter 1 Introduction
Thank you for purchasing the 14 COLOR UPGRADE KIT for XF-1600. This manual explains how to operate
the Sysmex Flow Cytometer XF-1600 when upgraded to 14 fluorescence detection channels by using the 14
COLOR UPGRADE KIT.
Read and understand the contents of this manual before operating this product, and keep this manual in a
safe place for future reference.
This is not an inclusive manual. The explanations in this manual assume that you have already read the
XF-1600 Instructions for Use.
For basic operations of the instrument, see the XF-1600 Instructions for Use.
In vitro diagnostic medical device
Contact Addresses
1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan
Authorized representatives
Europe, Middle East and Africa
Bornbarch 1, 22848 Norderstedt, Germany
Tel +49 40 5 27 26-0 / Fax +49 40 5 27 26-100
Asia-Pacific
9 Tampines Grande #06-18 Singapore 528735
Tel +65-6221-3629 / Fax +65-6221-3687
Service and maintenance
Please contact your authorized local Sysmex representative.
The system described in this manual is marked with the CE mark, which
confirms compliance with the applicable requirements of:
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices
• Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment and its related amending
directives including (EU) 2015/863 amending Annex II of Directive 2011/65/
EU
Note:
• Data generated by the XF-1600 is not intended to replace professional judgment in the determination of
a diagnosis or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there are any
deviations from the instructions in this manual. If the instrument fails to function properly as a result of
either a user's operation not specified in this manual or a user's utilization of a program not specified by
Sysmex, the product warranty will be void.
Chapter 1 Introduction
XF-1600 Instructions for Use
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1.1 Points to note about this manual
• You may not reproduce the contents of this manual in whole or in part without permission from Sysmex
Corporation.
• Images in this manual related to the product are for illustrative purposes only and may not exactly match the
product itself.
• While we have taken all possible precautions to ensure the quality of this manual, please contact your authorized
local Sysmex representative if you find any errors or omissions.
1.2 Symbols used in this manual
Note:
Indicates useful information for using the instrument.
Chapter 2 Instrument specifications
XF-1600 Instructions for Use
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Chapter 2 Instrument specifications
2.1 Optics
The semiconductor laser light (488 nm, 638 nm, and 405 nm) interrogates the cells and particles passing through the
flow cell. The forward scattered light is detected by a photodiode, and the side-scattered light and fluorescence are
detected by a photomultiplier. The light signals received by each detector are converted into electrical signals, and by
analyzing these signals, cell and particle information can be obtained.
Channel Laser wavelength Fluorochromes or FSC/SSC Optical filters
FSC 488 nm Forward scatter -
SSC Side scatter -
FL1 FITC 530/30
FL2 PE 580/30
FL3 PE-DyLight 594 610/14
FL4 PerCP-Cy5.5 700/50
FL5 PE-Cy7 750LP
FL6 638 nm APC 660/20
FL7 Alexa Fluor 700 720/40
FL8 APC-Cy7 780/60
Laser Diode (488 nm)
Flow cell
FL6 FL7
FL2 FL1
FL4 FL3
FL9
FL10
Laser Diode (638 nm) Laser Diode (405 nm)
FL8
Forward Scatter (FSC)
Side Scatter (SSC)
FL5
FL11
FL12
FL13
FL14
Chapter 2 Instrument specifications
XF-1600 Instructions for Use
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* For information about the fluorochromes that are suitable for your use environment, please contact your
authorized local Sysmex representative.
FL9 405 nm Pacific Blue 450/50
FL10 Pacific Orange 540/80
FL11 -* 603/30
FL12 -* 670/24
FL13 -* 710/50
FL14 -* 750LP
Channel Laser wavelength Fluorochromes or FSC/SSC Optical filters
Chapter 3 Cytometer QC and setup
XF-1600 Instructions for Use
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Chapter 3 Cytometer QC and setup
3.1 Registering lot information
Once the instrument is upgraded to 14 fluoroescence detection channels, QC files that were set up before the
upgrade cannot be used for measurement. To use the same lot of the quality control material, a new QC file must be
created.
For details on how to create a new QC file, see the following section:
("Chapter 9: 9.7 Registering lot information" in the XF-1600 Instructions for Use)
Chapter 3 Cytometer QC and setup
XF-1600 Instructions for Use
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Chapter 4 Registering panel/subset panel and workitems
XF-1600 Instructions for Use
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Chapter 4 Registering panel/subset panel and workitems
4.1 Reviewing subset panels and QC files
When the instrument is upgraded to 14 fluorescence detection channels, the positions of populations may move
slightly. Perform the following procedure:
1 Review the subset panel analysis conditions that are registered before the
upgrade.
("Chapter 10: 10.3 Registering subset panel analysis conditions while running a sample" in the XF-1600
Instructions for Use)
2 Review the baseline of related panel QC files.
("Chapter 11: 11.9 Managing panel QC files" in the XF-1600 Instructions for Use)
4.2 Workitems
Note:
• The workitems that are measured before upgrading the instrument to 14 fluorescence detection
channels do not include data for the additional fluorescence detection channels.
• Do not measure workitems that are registered before the upgrade